Anna Hrehlevych
ConsultantJob Description
- Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.
- Review batch records and automation-generated batch exceptions, escalating unexplained gaps or discrepancies.
- Support deviations, root cause, CAPAs, change control and effectiveness checks.
- Conduct GMP walkdowns and assess temporary manual workarounds and contemporaneous documentation.
- Work with automation/DI SMEs on recipe changes, alarm/event histories, historian evidence and batch record reconciliation.
- Support inspection walkthroughs and disposition documentation without assuming batch release authority.
- 8+ years (or 5+ with strong biologics floor experience, flagged for D09) in QA Operations within GMP biopharmaceutical manufacturing.
- Working knowledge of 21 CFR 210/211 and EU GMP; hands-on deviation, CAPA and batch record review.
- Eligible to work in Switzerland and able to work full time on site in Visp. Fluent English.
- Nice-to-have: German, mammalian cell-culture drug substance, DeltaV/MES eBR review, FDA inspection experience, Lean/Six Sigma, Veeva or TrackWise.
- CV keywords: batch record review, eBR, deviation, CAPA, biologics, 21 CFR 210/211, EU GMP, TrackWise, Veeva.
- Direct QA Operations experience in GMP biologics manufacturing; 8+ years or equivalent depth (thresholds under D09).
- Batch record/eBR review, deviation investigations, CAPA and operational change control.
- Ability to interpret DeltaV/MES-generated batch exceptions with qualified SMEs; onsite work eligibility in Switzerland.
- No QA Operations experience in GMP biologics manufacturing.
- Not eligible to work in Switzerland, or unable to work full time on site.
- Not available on any of the listed start dates.
- Reviewed batch records/exception logs and documented escalations.
- Deviation/CAPA reviews, floor-readiness observations and closure evidence.
- Inspection walkthrough readiness and prioritized open-quality issues.
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We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.
Source Group International Ltd is acting as an Employment Business in relation to this vacancy